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Biocidal product factsheet - Last updated: 15/10/2019

Biocidal Product details

Trade name:

Ben's 30

Ben's 30 kullancs- és szúnyogriaszó aeroszol (pumpás)

Ben's Insect Repellent

Ben‘s 30

REPEL BITE XTREME

Εντομοαπωθητικό Ben’s

Product-type:

PT19

Active Substance details

Substance name:

IUPAC name:

N,N-diethyl-m-toluamide

EC number:

205-149-7

CAS number:

134-62-3

BAS number:

23

Authorised
Authorisation information

Authorisation type:

National authorisation

Legal act:

10 authorisations in the product cluster
Authorisation number SPC Decisions

Ben's Insect Repellent

PT19

United Kingdom

Ardern Healthcare Limited UK-0008929-0000 UK-2016-1008 01/08/2016 26/07/2026

Single SPC  (en)

Authorised

Εντομοαπωθητικό Ben’s

PT19

Cyprus

Laboratorio Chimico Farmaceutico A.Sella srl CY-0016695-0000 ΚΥ-0073 01/08/2016 26/07/2026

Single SPC  (el)

Bens insect repellent_auth.pdf (el) (20/03/2017)

ΚΥ-0073_Εντομοαπωθητικό Ben's.pdf (el)

Authorised

Ben's 30

PT19

Estonia

Laboratorio Chimico Farmaceutico A.Sella srl EE-0011394-0000 EE-NAMR2017-0083 01/08/2016 26/07/2026

Single SPC  (et)

EE-NAMR2017-0083_Ben's 30.pdf (et) (12/04/2017)

NA-TRS otsus Ben's Insect Repellent.pdf (et)

Authorised

Ben's 30 kullancs- és szúnyogriaszó aeroszol (pumpás)

PT19

Hungary

Laboratorio Chimico Farmaceutico A.Sella srl HU-0011371-0000 HU-2017-MA-19-00180-0000 01/08/2016 26/07/2026

Single SPC  (hu)

Decision regarding the transfer of Ben's kullancs- es szunyogriaszto aeroszol (pumpas).pdf (hu)

Authorised

Ben's 30

PT19

Ireland

Laboratorio Chimico Farmaceutico A.Sella srl IE-0011547-0000 IE/BPA 70334 01/08/2016 26/07/2026

Single SPC  (en)

IE-BPA 70334 Authorisation Cert_public.pdf (en)

IE-BPA 70334 Authorisation Cert Ver1.1.pdf (en)

Authorised

Ben's 30

PT19

Latvia

Laboratorio Chimico Farmaceutico A.Sella srl LV-0010624-0000 LV/2017/MR/005 01/08/2016 26/07/2026

Single SPC  (lv)

Authorised

Ben‘s 30

PT19

Lithuania

Laboratorio Chimico Farmaceutico A.Sella srl LT-0011503-0000 (10-14 17.5)BSV-2104(A-19BAP911848/A-19-24) 17/02/2017 26/07/2026

Single SPC  (lt)

1848 Bens 30 su bsv.doc (lt)

1848 A Authorisation Bens 30 2019.pdf (lt)

Authorised

Ben's Insect Repellent

PT19

Netherlands

Laboratorio Chimico Farmaceutico A.Sella srl NL-0018740-0000 - 03/08/2016 26/07/2026

Single SPC  (nl)

20190723_nl_0018740_0000_administrative_change.pdf (nl)

20172236_NL-0018740-0000_Authorisation.doc (nl)

Authorised

Ben's Insect Repellent

PT19

Slovenia

Laboratorio Chimico Farmaceutico A.Sella srl SI-0011344-0000 SI-0011344-0000 01/08/2016 26/07/2026

Single SPC  (sl)

Laboratorio_Chimico__Ben_s_Insect_re_P.pdf (sl)

Laboratorio_Chimico__Ben_s_Insect_Re_P.pdf (sl)

Authorised

REPEL BITE XTREME

PT19

Spain

ESTEVE PHARMACEUTICALS, S.A. ES-0009003-0000 ES/MR(NA)-2016-19-00391 01/08/2016 26/07/2026

Single SPC  (en)

00391 Repel Bite Xtreme.pdf (es) (19/01/2017)

R4BP-ES-0009003-0000-Authorisation.pdf (es)

Authorised
Reference authorisation
Trade name: Ben's Insect Repellent
Authorisation number: UK-0008929-0000| Market area: United Kingdom

3 assessment records available

Amendment of national authorisation

Evaluating authority:

United Kingdom

Conclusion date:

11/12/2018

Validity of authorisation

Start date:

01/08/2016

End date:

26/07/2026

SPC

Single SPC  (en)

Amendment of national authorisation

Evaluating authority:

United Kingdom

Conclusion date:

12/01/2017

Validity of authorisation

Start date:

01/08/2016

End date:

26/07/2026

SPC

SPC not available

Application of national authorisation

Evaluating authority:

United Kingdom

Conclusion date:

01/08/2016

Validity of authorisation

Start date:

01/08/2016

End date:

26/07/2026

SPC

SPC not available

Mutual recognition
Trade name: Εντομοαπωθητικό Ben’s
Authorisation number: CY-0016695-0000| Market area: Cyprus

2 assessment records available

Transfer of a national authorisation

Evaluating authority:

Cyprus

Conclusion date:

29/03/2019

Validity of authorisation

Start date:

01/08/2016

End date:

26/07/2026

SPC

Single SPC  (el)

Mutual recognition in sequence

Evaluating authority:

Cyprus

Conclusion date:

20/03/2017

Validity of authorisation

Start date:

01/08/2016

End date:

26/07/2026

SPC

SPC not available

Trade name: Ben's 30
Authorisation number: EE-0011394-0000| Market area: Estonia

2 assessment records available